Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Flomaxtra XL, 400 micrograms, film-coated prolonged release tablet
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Tamsulosin hydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
What is Flomaxtra XL Flomaxtra XL contains the active substance tamsulosin hydrochloride. It acts by relaxing the muscles in the prostate and urethra (the tube that carries urine to the outside), and lets urine pass more readily through the urethra and aids urination. In the prostate gland, bladder and urethra there are specialised cells containing alpha1A-receptors that cause the muscles in the urethra to tighten. Flomaxtra XL is an alpha1A-adrenoceptor blocker, which reduces the action of these specialised cells and relaxes the muscles making it easier to pass water. What Flomaxtra XL is used for Flomaxtra XL is used to treat the symptoms associated with benign prostatic hyperplasia (BPH) which is enlargement of the prostate gland. These symptoms include difficulty in starting to pass water, frequent trips to the toilet to pass water, a feeling of not completely emptying the bladder and having to get up several times in the night to pass water. 2.
What you need to know before you take it
e Flomaxtra XL
Do not use Flomaxtra XL if you
- are allergic to tamsulosin or any of the other ingredients of Flomaxtra XL (listed in section 6)
- have a severe liver condition
- have ever fainted or felt dizzy when suddenly sitting or standing up. Dizziness can sometimes occur when taking Flomaxtra XL, particularly if you are also taking other alpha1blockers. If you do feel weak or dizzy make sure you sit or lie down straight away until the symptoms have disappeared. Warnings and precautions Talk to your doctor before using Flomaxtra XL
- If you have kidney problems
- If you are undergoing or have been scheduled for eye surgery because of cloudiness of the lens (cataract) or increased pressure in the eye (glaucoma).
1
Please inform your eye specialist that you have previously used, are using or are planning to use tamsulosin hydrochloride. The specialist can then take appropriate precautions with respect to medication and surgical techniques to be used. Ask your doctor whether or not you should postpone or temporarily stop taking this medicine when undergoing eye surgery because of a cloudy lens (cataract) or increased pressure in the eye (glaucoma). Children and adolescents Do not give this medicine to children or adolescents under 18 years because it does not work in this population. Other medicines and Flomaxtra XL Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Flomaxtra XL can affect the way that some other medicines work and some other medicines can affect the way that Flomaxtra XL works. In particular tell your doctor or pharmacist if you are taking:
- Medicines to lower your blood pressure such as verapamil and diltiazem
- Medicines to treat HIV such as ritonavir or indinavir.
- Medicines to treat a fungal infection such as ketaconazole or itraconazole
- Other alpha blockers such as doxazosin, indoramin, prazosin or alfuzosin
- Erythromycin, an antibiotic used to treat infections Please inform your doctor that you are on Flomaxtra XL before any operation or dental procedure as there is a potential that your medicine may interfere with the effects of the anaesthetic. Pregnancy, breast-feeding and fertility Flomaxtra XL is not indicated for use in women. In men, abnormal ejaculation has been reported (ejaculation disorder). This means that the semen does not leave the body via the urethra, but instead goes into the bladder (retrograde ejaculation) or the ejaculation volume is reduced or absent (ejaculation failure). This phenomenon is harmless. Driving and using machines There is no information available on whether Flomaxtra XL affects the ability to drive or to operate machinery or equipment. However, it is known that Flomaxtra XL may cause drowsiness, blurred vision, dizziness and fainting. If you suffer from these do not drive or operate machinery. 3.
How to take it
Flomaxtra XL
Always take this medicine exactly as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure. The recommended dose for adults and the elderly is one tablet each day. It can be taken with or without food. Swallow the tablet whole. Do not crunch or chew. Your doctor may want to examine you from time to time whilst you are taking this medicine. If you take more Flomaxtra XL than you should If you have taken too many tablets, contact your doctor immediately or go to the nearest hospital casualty department taking any remaining medication and this patient information leaflet with you. If you forget to take Flomaxtra XL You may take your tablet later the same day if you have forgotten to take it earlier. If you have missed a day, just continue to take your daily tablet from the next day. Do not take a double dose to make up for a missed dose. If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.
2
4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking this medicine and consult your doctor immediately if any of the following occur – you may need medical treatment. Rare (affects less than 1 in 1000 people)
- Swelling of the face, throat or tongue with breathing problems linked to allergy. Very rare (affects less than 1 in 10,000 people)
- Persistent painful erection usually unrelated to sexual activity.
- Rash, inflammation and blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages or genitals (Stevens-Johnson syndrome).
- Abnormal irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia), difficult breathing (dyspnoea). The following side effects have also been reported: Common (affects less than 1 in 10 people)
- dizziness
- abnormal ejaculation (ejaculation disorder). This means that semen does not leave the body via the urethra, but instead goes into the bladder (retrograde ejaculation) or the ejaculation volume is reduced or absent (ejaculation failure). This phenomenon is harmless. Uncommon (affects less than 1 in 100 people)
- weakness
- headache
- runny or blocked nose
- dizziness as you sit or stand up
- palpitations (rapid or irregular heart beat)
- gastro-intestinal symptoms such as nausea and vomiting (feeling or being sick), diarrhoea or constipation
- hypersensitivity reactions such as rash, itching, redness, local swelling and breathing problems Rare (affects less than 1 in 1000 people)
- fainting Not known (frequency cannot be estimated from the available data):
- blurred vision
- impaired vision
- nose bleeds (epistaxis)
- serious skin rashes (erythema multiforme, dermatitis exfoliative)
- dry mouth As with other medicines of this type, drowsiness, blurred vision or swelling of the hands and feet can occur. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
3
5.
How to store it
Flomaxtra XL
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton (EXP). The expiry date refers to the last day of that month. This medicine does not require any special storage conditions. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment. 6.
Contents of the pack and other information
What Flomaxtra XL contains The active substance is tamsulosin hydrochloride. Each prolonged-release tablet contains 400 micrograms tamsulosin hydrochloride which is equivalent to 367 micrograms of tamsulosin. The other ingredients are macrogol, magnesium stearate, butylhydroxytoluene, hypromellose and yellow iron oxide E172. What Flomaxtra XL looks like and contents of the pack Flomaxtra XL tablets are round, yellow tablets with `04 ́ imprinted on them. The tablets are supplied in blister packs of 30. Marketing Authorisation Holder and Manufacturer Marketing authorisation holder: Astellas Pharma Ltd. 300 Dashwood Lang Road Bourne Business Park Addlestone United Kingdom KT15 2NX Manufacturer: Delpharm Meppel B.V., Hogemaat 2, 7942 JG Meppel, The Netherlands This leaflet was last revised in January 2025.
4
Frequently asked questions about Flomaxtra XL, 400 micrograms, film-coated prolonged release tablet
How do I take Flomaxtra XL, 400 micrograms, film-coated prolonged release tablet?
Flomaxtra XL, 400 micrograms, film-coated prolonged release tablet comes as tablet containing 400mcg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Flomaxtra XL, 400 micrograms, film-coated prolonged release tablet?
The active substance in Flomaxtra XL, 400 micrograms, film-coated prolonged release tablet is tamsulosin hydrochloride.
Are there equivalent medicines to Flomaxtra XL, 400 micrograms, film-coated prolonged release tablet?
Medicines with the same active substance, strength and form include: Tamsulosin prolonged release tablets 400 microgram. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Flomaxtra XL, 400 micrograms, film-coated prolonged release tablet, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Flomaxtra XL, 400 micrograms, film-coated prolonged release tablet without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: tamsulosin hydrochloride
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Flomaxtra XL in indicated in adults for the treatment of functional symptoms of benign prostatic hyperplasia (BPH).
4.2. Posology and method of administration
Posology
One tablet daily, to be taken with or without food.
Paediatric Population
The safety and efficacy of tamsulosin in children <18 years have not been established.
Currently available data are described in Section 5.1.
Method of administration
For oral use.
The tablet should be swallowed whole and should not be crunched or chewed as this will interfere with the prolonged release of the active ingredient.
4.3. Contraindications
A history of orthostatic hypotension; severe hepatic insufficiency.
Hypersensitivity to the active substance, or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
As with other alpha1 blockers, a reduction in blood pressure can occur in individual cases during treatment with Flomaxtra XL, as a result of which, rarely, syncope can occur. At the first signs of orthostatic hypotension (dizziness, weakness), the patient should sit or lie down until the symptoms have disappeared.
Before therapy with Flomaxtra XL is initiated, the patient should be examined in order to exclude the presence of other conditions which can cause the same symptoms as benign prostatic hyperplasia. Digital rectal examination and, when necessary, determination of prostate specific antigen (PSA) should be performed before treatment and at regular intervals afterwards.
The treatment of severely renally impaired patients (creatinine clearance of less than 10 ml/min) should be approached with caution as these patients have not been studied.
The 'Intraoperative Floppy Iris Syndrome' (IFIS, a variant of small pupil syndrome) has been observed during cataract and glaucoma surgery in some patients on or previously treated with tamsulosin hydrochloride. IFIS may increase the risk of eye complications during and after the operation.
Discontinuing tamsulosin hydrochloride 1-2 weeks prior to cataract or glaucoma surgery is anecdotally considered helpful, but the benefit of treatment discontinuation has not been established. IFIS has also been reported in patients who had discontinued tamsulosin for a longer period prior to the surgery.
The initiation of therapy with tamsulosin hydrochloride in patients for whom cataract or glaucoma surgery is scheduled is not recommended. During pre-operative assessment, surgeons and ophthalmic teams should consider whether patients scheduled for cataract or glaucoma surgery are being or have been treated with tamsulosin in order to ensure that appropriate measures will be in place to manage the IFIS during surgery.
Tamsulosin hydrochloride should not be given in combination with strong inhibitors of CYP3A4 (e.g. ketoconazole) in patients with poor metaboliser CYP2D6 phenotype.
Tamsulosin hydrochloride should be used with caution in combination with strong (e.g. ketoconazole) and moderate (e.g. erythromycin) inhibitors of CYP3A4 (see section 4.5).
4.5. Interaction with other medicinal products and other forms of interaction
No interactions have been seen when tamsulosin was given concomitantly with atenolol, enalapril, or theophylline. Concomitant cimetidine brings about a rise in plasma levels of tamsulosin, and furosemide a fall, but as levels remain within the normal range, posology need not be changed.
In vitro, neither diazepam nor propranolol, trichlormethiazide, chlormadinon, amitryptyline, diclofenac, glibenclamide, simvastatin and warfarin change the free fraction of tamsulosin in human plasma. Neither does tamsulosin change the free fractions of diazepam, propranolol, trichlormethiazide, and chlormadinon.
Diclofenac and warfarin, however, may increase the elimination rate of tamsulosin.
Concomitant administration of tamsulosin hydrochloride with strong inhibitors of CYP3A4 may lead to increased exposure to tamsulosin hydrochloride. Concomitant administration with ketoconazole (a known strong CYP3A4 inhibitor) resulted in an increase in AUC and Cmax of tamsulosin hydrochloride by a factor of 2.8 and 2.2, respectively.
Tamsulosin hydrochloride should not be given in combination with strong inhibitors of CYP3A4 (e.g. ketoconazole) in patients with poor metaboliser CYP2D6 phenotype.
Tamsulosin hydrochloride should be used with caution in combination with strong (e.g. ketoconazole) and moderate inhibitors (e.g. erythromycin) of CYP3A4.
Concomitant administration of tamsulosin hydrochloride with paroxetine, a strong inhibitor of CYP2D6, resulted in a Cmax and AUC of tamsulosin that had increased by a factor of 1.3 and 1.6, respectively, but these increases are not considered clinically relevant.
There is a theoretical risk of enhanced hypotensive effect when given concurrently with drugs which may reduce blood pressure, including anaesthetic agents and other α1-adrenoceptor antagonists.
4.6. Fertility, pregnancy and lactation
Flomaxtra XL is not indicated for use in women.
Ejaculation disorders have been observed in short and long term clinical studies with tamsulosin. Events of ejaculation disorder, retrograde ejaculation and ejaculation failure have been reported in the post authorisation phase.
4.7. Effects on ability to drive and use machines
No data is available on whether Flomaxtra XL adversely affects the ability to drive or operate machines. However, in this respect patients should be aware of the fact that drowsiness, blurred vision, dizziness and syncope can occur.
4.8. Undesirable effects
Tabulated list of adverse reactions
System Organ Class
Common
>1/100, <1/10
Uncommon
>1/1000, <1/100
Rare
>1/10,000, <1/1000
Very Rare
<1/10,000
Not known (cannot be estimated from the available data)
Nervous system disorders
dizziness (1.3%)
headache
syncope
Eye disorders
Vision blurred*
Visual impairment*
Cardiac disorders
palpitations
Vascular disorders
orthostatic hypotension
Respiratory, thoracic and mediastinal disorders
rhinitis
Epistaxis*
Gastrointestinal disorders
constipation, diarrhoea, nausea, vomiting
Dry mouth*
Skin and subcutaneous tissue disorders
rash, pruritis, urticaria
angioedema
Stevens-Johnson syndrome
Erythema multiforme*
Dermatitis exfoliative*
Reproductive system and breast disorders
ejaculation disorders including retrograde ejaculation and ejaculation failure
priapism
General disorders and administration site conditions
asthenia
*observed post-marketing
As with other alpha-blockers, drowsiness, blurred vision or oedema can occur.
During cataract and glaucoma surgery a small pupil situation, known as Intraoperative Floppy Iris Syndrome (IFIS), has been associated with therapy of tamsulosin during post-marketing surveillance (see also section 4.4).
Post-marketing experience: In addition to the adverse events listed above, atrial fibrillation, arrhythmia, tachycardia and dyspnoea have been reported in association with tamsulosin use. Because these spontaneously reported events are from the worldwide post marketing experience, the frequency of events and the role of tamsulosin in their causation cannot be reliably determined.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Symptoms
Overdosage with tamsulosin hydrochloride can potentially result in severe hypotensive effects, dizziness and malaise. Severe hypotensive effects have been observed at different levels of overdosing.
Treatment
In case of acute hypotension occurring after overdose, cardiovascular support should be given. Blood pressure can be restored and heart rate brought back to normal by lying the patient down. If this does not help, then volume expanders, and when necessary, vasopressors could be employed. Renal function should be monitored and general supportive measures applied. Dialysis is unlikely to be of help, as tamsulosin is very highly bound to plasma proteins.
Measures, such as emesis, can be taken to impede absorption. When large quantities are involved, gastric lavage can be applied and activated charcoal and an osmotic laxative, such as sodium sulfate, can be administered.
💬 Ask about this leaflet
Ask anything about Flomaxtra XL, 400 micrograms, film-coated prolonged release tablet. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.